Phase 3 Trial of Keytruda Plus Lenvima Combination Meets Dual Primary Endpoints, Reducing Risk of Death by 38% in Advanced Endometrial Cancer

MSD and Eisai Announce That Combination Therapy of PD-1 Inhibitor Keytruda and Tyrosine Kinase Inhibitor Lenvima Met Dual Primary Endpoints in Phase 3 Trial for Previously Treated Patients with Advanced, Metastatic, or Recurrent Endometrial Cancer, Significantly Improving Progression-Free Survival (PFS) and Overall Survival (OS) Compared to Chemotherapy

Endometrial cancer is the sixth most common cancer among women worldwide. In 2020, there were over 410,000 new cases diagnosed, and nearly 100,000 patients died from the disease. Currently, platinum-based chemotherapy serves as the first-line treatment; however, therapeutic options are very limited after first-line therapy fails. Endometrial cancer can be classified into two categories: microsatellite stable (MSS), accounting for 75% of cases, and microsatellite instability-high (MSI-H), accounting for 25%. For patients with recurrent disease, there is currently only one approved therapy targeting the subset of patients with MSI-H tumors, while no approved therapies exist for the subset of patients with MSS tumors. The five-year survival rate for patients with metastatic endometrial cancer is 17%.

The combination therapy comprising the PD-1 inhibitor Keytruda and the tyrosine kinase inhibitor Lenvima is one of MSD’s key development programs. This regimen has demonstrated positive outcomes in clinical trials across multiple cancer types, including hepatocellular carcinoma, renal cell carcinoma, and gastric cancer. In 2019, based on objective response rate, the combination received accelerated approval from the FDA for the treatment of endometrial cancer. The Phase 3 clinical trial results announced today further validate that this combination therapy provides survival benefits to patients.

The trial results showed that in all patients (including MSS and MSI-H), the median PFS for the Keytruda/Lenvima group was 7.2 months, significantly superior to 3.8 months for the chemotherapy group (HR=0.56, p<0.0001). Furthermore, the Keytruda/Lenvima combination reduced the risk of death by 38%. The median overall survival for patients receiving Keytruda/Lenvima was 18.3 months, compared to 11.4 months for the chemotherapy group.

“Survival rates are low for patients with advanced-stage endometrial cancer, particularly those whose disease has progressed following platinum-based chemotherapy,” said Dr. Vicky Makker, principal investigator of the clinical trial and a physician at Memorial Sloan Kettering Cancer Center. “It is highly encouraging to observe a 38% reduction in the risk of death, regardless of patients’ microsatellite instability status.”

References:

[1] KEYTRUDA^® (pembrolizumab) Plus LENVIMA^® (lenvatinib) Significantly Improved Progression-Free Survival and Overall Survival Versus Chemotherapy in Patients With Advanced Endometrial Cancer Following Prior Platinum-Based Chemotherapy in Phase 3 Study. Retrieved March 19, 2021, from https://www.businesswire.com/news/home/20210319005069/en

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